Details for Patent: 8,497,284

Which drugs does patent 8,497,284 protect, and when does it expire?

Patent 8,497,284 protects CABOMETYX and is included in one NDA.

This patent has seventy-four patent family members in seventeen countries.

Summary for Patent: 8,497,284

Title:	C-met modulators and method of use
Abstract:	The present invention provides compounds for modulating protein kinase enzymatic activity for modulating cellular activities such as proliferation, differentiation, programmed cell death, migration and chemoinvasion. More specifically, the invention provides quinazolines and quinolines which inhibit, regulate, and/or modulate kinase receptor, particularly c-Met, KDF, c-Kit, flt-3 and flt-4, signal transduction pathways related to the changes in cellular activities as mentioned above, compositions which contain these compounds, and methods of using them to treat kinase-dependent diseases and conditions. The present invention also provides methods for making compounds as mentioned above, and compositions which contain these compounds.
Inventor(s):	Bannen; Lynne Canne (Lucerne, CA), Chan; Diva Sze-Ming (Oakland, CA), Chen; Jeff (San Francisco, CA), Dalrymple; Lisa Esther (Seattle, WA), Forsyth; Timothy Patrick (Hayward, CA), Huynh; Tai Phat (Oakland, CA), Jammalamadaka; Vasu (Pleasanton, CA), Khoury; Richard George (San Mateo, CA), Leahy; James William (San Leandro, CA), Mac; Morrison B. (San Francisco, CA), Mann; Grace (San Mateo, CA), Mann; Larry W. (Richland, MI), Nuss; John M. (Danville, CA), Parks; Jason Jevious (Sacramento, CA), Takeuchi; Craig Stacy (Burlingame, CA), Wang; Yong (Foster City, CA), Xu; Wei (Danville, CA)
Assignee:	Exelixis, Inc. (South San Francisco, CA)
Application Number:	13/249,815
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,497,284
Patent Claim Types: see list of patent claims	Use; Composition;

United States Patent 8,497,284: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 8,497,284, titled "C-met modulators and method of use," is a significant patent in the field of pharmaceuticals, particularly in the development and use of tyrosine kinase inhibitors. This patent, owned by Exelixis, Inc., has been at the center of several legal battles and is crucial for understanding the patent landscape in the realm of cancer treatment.

Background and Invention

The patent, issued on July 30, 2013, and set to expire on September 24, 2024, describes compounds designed to modulate the activity of the c-Met (hepatocyte growth factor receptor) protein kinase. These compounds are intended to treat various cancers and other diseases by inhibiting the c-Met pathway, which is often involved in tumor growth and metastasis[1][5].

Claims of the Patent

The '284 Patent includes multiple claims that define the scope of the invention. These claims cover:

• Specific chemical compounds and their salts.
• Methods of treating diseases, including various types of cancer such as medullary thyroid cancer, renal cell carcinoma, and hepatocellular carcinoma.
• Pharmaceutical compositions containing these compounds.
• Processes for preparing these compounds[1][5].

Key Claims

• Claims 1, 8, 18, and 23 are particularly significant as they have been asserted in infringement cases against MSN Laboratories Private Ltd. and MSN Pharmaceuticals Inc. These claims pertain to the specific chemical structures of the c-Met modulators and their use in treating cancer[5].

Patent Scope and Metrics

The scope of the '284 Patent can be analyzed using metrics such as independent claim length and independent claim count. These metrics help in understanding the breadth and complexity of the patent claims. Generally, patents with longer independent claims and a higher number of independent claims tend to have broader scope and potentially greater impact on the industry[3].

Patent Landscape and Litigation

The '284 Patent is part of a larger patent portfolio held by Exelixis, which includes other patents such as U.S. Patent Nos. 7,579,473 and 8,877,776. These patents collectively protect the company's tyrosine kinase inhibitor, cabozantinib, marketed as CABOMETYX®.

Infringement Cases

Exelixis has filed several complaints against MSN Laboratories and MSN Pharmaceuticals for patent infringement related to the filing of an Abbreviated New Drug Application (ANDA) for a generic version of CABOMETYX®. The cases involve allegations that MSN's actions would infringe claims of the '284 Patent, among others, if the ANDA is approved[2][5].

Expert Opinions and Court Rulings

In the litigation, experts such as Dr. Salvatore Lepore and Dr. Jonathan Steed have provided opinions on the obviousness of the '284 Patent under 35 U.S.C. § 103. Despite these challenges, a stipulated judgment of infringement for the '473 and '284 patents was entered in the consolidated case on October 1, 2021, indicating that the claims of these patents were found not invalid if they stand[2].

Impact on the Pharmaceutical Industry

The '284 Patent and related patents have significant implications for the pharmaceutical industry, particularly in the development of generic drugs. The litigation surrounding these patents highlights the complexities and challenges faced by generic drug manufacturers in navigating the patent landscape.

Innovation and Licensing

The broad scope and enforcement of these patents can influence innovation by affecting the incentives for other companies to develop similar drugs. High licensing and litigation costs associated with such patents can diminish these incentives, as discussed in debates over patent quality and scope[3].

Expiration and Future Implications

With the '284 Patent set to expire on September 24, 2024, the landscape for c-Met modulators and similar tyrosine kinase inhibitors is expected to change. The expiration will open up opportunities for generic manufacturers to enter the market, potentially increasing competition and reducing costs for patients.

Conclusion

The United States Patent 8,497,284 is a critical component of Exelixis's intellectual property portfolio, protecting key aspects of their cancer treatment drug, CABOMETYX®. The patent's scope, claims, and the associated litigation underscore the importance of patent law in the pharmaceutical industry, influencing both innovation and market competition.

Key Takeaways

• The '284 Patent covers specific c-Met modulators and their use in treating various cancers.
• The patent has been central in infringement cases against MSN Laboratories and MSN Pharmaceuticals.
• The scope and claims of the patent are broad, impacting the development of generic drugs.
• The patent's expiration in 2024 will likely change the market dynamics for tyrosine kinase inhibitors.
• The litigation surrounding this patent highlights the complexities of patent law in the pharmaceutical industry.

Frequently Asked Questions (FAQs)

What is the main subject of the United States Patent 8,497,284?

The main subject of the '284 Patent is c-Met modulators and their methods of use, particularly in treating various types of cancer.

Who owns the '284 Patent?

The '284 Patent is owned by Exelixis, Inc.

What are the key claims of the '284 Patent?

The key claims include specific chemical compounds, methods of treating diseases, pharmaceutical compositions, and processes for preparing these compounds.

What is the significance of the litigation involving the '284 Patent?

The litigation involves allegations of patent infringement by MSN Laboratories and MSN Pharmaceuticals, highlighting the importance of patent protection in the pharmaceutical industry.

When is the '284 Patent set to expire?

The '284 Patent is set to expire on September 24, 2024.

Cited Sources:

1. US8497284B2 - C-met modulators and method of use - Google Patents
2. Defendants Allowed to Hide the Ball on Their Combination of Prior Art References - Finnegan
3. Patent Claims and Patent Scope - Hoover Institution
4. Form 10-Q for Exelixis INC filed 08/06/2024 - Exelixis
5. IN THE UNITED STATES DISTRICT COURT FOR THE ... - RPX Insight

Drugs Protected by US Patent 8,497,284

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-001	Apr 25, 2016		RX	Yes	No	8,497,284					TREATMENT OF RENAL CELL CARCINOMA
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-001	Apr 25, 2016		RX	Yes	No	8,497,284					TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-001	Apr 25, 2016		RX	Yes	No	8,497,284					TREATMENT OF ADVANCED RENAL CELL CARCINOMA

International Family Members for US Patent 8,497,284

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2213661		C300678	Netherlands
European Patent Office	2213661		CA 2014 00039	Denmark
European Patent Office	2213661		PA2014033	Lithuania